Trial · NCT02034162
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
NCT02034162, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2016-11-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants. Trials, record NCT02034162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02034162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
- NCT number
- NCT02034162
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Helminth Infections
- Interventions
- Mebendazole, Placebo
- First posted
- 2014-01-13
- Last updated
- 2016-11-04
- Results first posted
- 2016-11-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | At Visit 3 (Day 19) of Double-blind treatment period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. |
| Primary | Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | At Visit 3 (Day 19) of Double-blind treatment period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. |
| Primary | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | Up to Visit 3 (Day 19 +/-2) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Primary | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period | At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Secondary | Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. |
| Secondary | Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. |
| Secondary | Maximum Plasma Concentration (Cmax) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | The Cmax is the maximum plasma concentration. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose. |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | The (AUC \[0-last\]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | At Visit 3 (Day 19) of Double-blind treatment period | The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | At Visit 3 (Day 19) of Double-blind treatment period | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | Up to Visit 3 (Day 19 +/-2) | The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure. | participants | NUMBER |
| SECONDARY | Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | percent change in egg count | NUMBER |
| SECONDARY | Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | percent change in egg count | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | nanogram per Milliliters (ng/mL) | MEAN |
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period | At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3) | The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure. | participants | NUMBER |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | hours | MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | nanogram hour per Milliliters(ng*h/mL) | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | ng*h/mL | MEAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | Double-blind Placebo | 11.1 | 95% Confidence Interval 5.2 to 20.1 | percentage of participants | |
| Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | Double-blind Mebendazole 500 mg | 83.7 | 95% Confidence Interval 74.2 to 90.8 | percentage of participants | |
| Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | Double-blind Placebo | 7.6 | 95% Confidence Interval 3.5 to 13.9 | percentage of participants | |
| Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | Double-blind Mebendazole 500 mg | 33.9 | 95% Confidence Interval 25.6 to 42.9 | percentage of participants | |
| Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | Double-blind Placebo | 8 | participants | ||
| Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | Double-blind Mebendazole 500 mg | 9 | participants | ||
| Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Double-blind Placebo | -19.2 | 20684.03 | percent change in egg count | |
| Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Double-blind Mebendazole 500 mg | -97.9 | 23476.82 | percent change in egg count | |
| Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Double-blind Placebo | -10.5 | 930.05 | percent change in egg count | |
| Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Double-blind Mebendazole 500 mg | -59.7 | 1256.22 | percent change in egg count |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind | STARTED | Double-blind Placebo | 146 | |
| Double-blind | STARTED | Double-blind Mebendazole 500 mg | 149 | |
| Double-blind | STARTED | Open-label Mebendazole 500 mg | 0 | |
| Double-blind | COMPLETED | Double-blind Placebo | 137 | |
| Double-blind | COMPLETED | Double-blind Mebendazole 500 mg | 141 | |
| Double-blind | COMPLETED | Open-label Mebendazole 500 mg | 0 | |
| Double-blind | NOT COMPLETED | Double-blind Placebo | 9 | |
| Double-blind | NOT COMPLETED | Double-blind Mebendazole 500 mg | 8 | |
| Double-blind | NOT COMPLETED | Open-label Mebendazole 500 mg | 0 | |
| Open-label | STARTED | Double-blind Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events57
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Night Blindness | Eye disorders | Double-blind Placebo | 1 | 140 | |
| other | Night Blindness | Eye disorders | Double-blind Mebendazole 500 mg | 0 | 144 | |
| other | Night Blindness | Eye disorders | OL Mebendazole 500 mg | 0 | 278 | |
| other | Abdominal Distension | Gastrointestinal disorders | Double-blind Placebo | 1 | 140 | |
| other | Abdominal Distension | Gastrointestinal disorders | Double-blind Mebendazole 500 mg | 2 | 144 | |
| other | Abdominal Distension | Gastrointestinal disorders | OL Mebendazole 500 mg | 0 | 278 | |
| other | Abdominal Pain | Gastrointestinal disorders | Double-blind Placebo | 1 | 140 | |
| other | Abdominal Pain | Gastrointestinal disorders | Double-blind Mebendazole 500 mg | 1 | 144 | |
| other | Abdominal Pain | Gastrointestinal disorders | OL Mebendazole 500 mg | 1 | 278 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Placebo | 0 | 140 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Placebo | ||
| Total, all-cause mortality | Double-blind Mebendazole 500 mg | ||
| Total, all-cause mortality | OL Mebendazole 500 mg | ||
| Total, other adverse events | Double-blind Placebo | 8 | 140 |
| Total, other adverse events | Double-blind Mebendazole 500 mg | 9 | 144 |
| Total, other adverse events | OL Mebendazole 500 mg | 7 | 278 |
| Total, serious adverse events | Double-blind Placebo | 0 | 140 |
| Total, serious adverse events | Double-blind Mebendazole 500 mg | 0 | 144 |
| Total, serious adverse events | OL Mebendazole 500 mg | 0 | 278 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Double-blind Mebendazole 500 mg vs Double-blind Placebo: Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02034162
GET https://conductscience.org/api/trials/v1/NCT02034162/results?page=2